Recall Record

West Chester, PA, United States

Synthes (USA) Products LLC recalls

20 recalls recorded since 2018, most recently on 25 February 2026. 9 are listed as ongoing. Status and classification are as published by the FDA.

Recalls20
Ongoing (FDA)9
Terminated or completed11
Class I (FDA)0

Ongoing Class II Medical devices

Recall started
25 February 2026
Reason
A full lot swap between VOLT Locking Screw Tap 03.424.124 lot 68900P9 and Cortical Screw Tap 03.424.126 lot 68982P8, resulting in the bones taps having an incorrect thread.
Distribution
US Nationwide distribution in the states of AR, AZ, CA, CO, FL, IN, LA, MD, MN, NC, NJ, OH, OK, OR, PA, TN, TX, UT, VA, WA, WI.
Initiated
Voluntary: Firm initiated
Recall numbers
Z-1702-2026, Z-1703-2026

Ongoing Class II Medical devices

Recall started
26 September 2025
Reason
Although the etched length on the screw is correct, the length marked on the external packaging is incorrect. Specifically, 42mm screws were packaged and labeled as 46mm, while 46mm screws were packaged and labeled as 42mm.
Distribution
Worldwide - US Nationwide distribution in the states of AL, AR, AZ, CA, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NJ, NM, NY, OH, TN, TX and the country of Canada.
Initiated
Voluntary: Firm initiated
Recall numbers
Z-0228-2026, Z-0229-2026

Ongoing Class II Medical devices

Recall started
25 April 2024
Reason
Stardrive Screwdrivers manufactured without a 5-degree relief cut around the tip and will not engage with their respective 1.3mm and 1.5mm screws, may result in surgical delay
Distribution
Worldwide distribution - US Nationwide and the country of Canada.
Initiated
Voluntary: Firm initiated
Recall number
Z-1916-2024

Ongoing Class II Medical devices

Recall started
24 January 2024
Reason
Products not sterilized, sterility cannot be confirmed
Distribution
Worldwide distribution - US Nationwide and the countries of Argentina, Austria, Australia, Belgium, Canada, Czech Republic, Germany, Spain, Finland, France, United Kingdom, Ireland, South Korea, Kuwait, Mexico, Netherlands, Slovakia, Taiwan, South Africa.
Initiated
Voluntary: Firm initiated
Recall numbers
Z-1242-2024, Z-1238-2024, Z-1234-2024, Z-1239-2024, Z-1235-2024, Z-1241-2024, Z-1236-2024, Z-1237-2024, Z-1240-2024

Ongoing Class II Medical devices

Recall started
1 February 2023
Reason
TFNA Femoral Nails labeled and etched as 200mm may measure 170mm in length, and TFNA Femoral Nails labeled and etched as 170mm may measure 200mm in length
Distribution
Worldwide - US Nationwide distribution in the states of MS, OR, TX and the countries of Canada, Japan.
Initiated
Voluntary: Firm initiated
Recall numbers
Z-1246-2023, Z-1247-2023, Z-1248-2023

Ongoing Class II Medical devices

Recall started
27 September 2022
Reason
The subject products are being recalled because they contain the incorrect size drill guide and will not prepare the bone correctly for the size of the implant included in the sterile kit. If the incorrect drill guide is used, there is potential for bone damage due to incorrectly placed drill holes for the implant included in the kit.
Distribution
US Nationwide distribution.
Initiated
Voluntary: Firm initiated
Recall numbers
Z-0100-2023, Z-0101-2023, Z-0098-2023, Z-0099-2023

Ongoing Class II Medical devices

Recall started
30 August 2022
Reason
Drill Pin (drill bit) is not compatible with the Drill Template included in the kit due to a packaging error, result in a surgical delay and may cause soft tissue damage if a larger incision is required to accommodate an alternative form of fixation. Additionally, there is a potential for adverse tissue reaction if the surgeon attempts to use the guide regardless of tight fit and plastic debris is created and ends up in the wound
Distribution
US Nationwide distribution.
Initiated
Voluntary: Firm initiated
Recall number
Z-0008-2023

Ongoing Class II Medical devices

Recall started
7 April 2022
Reason
DePuy Synthes Radial Head Replacement System Contraindications added to Electronic Instructions for Use (e-IFU): Absolute contraindications include: Infection, sepsis, osteomyelitis.
Distribution
US Nationwide distribution.
Initiated
Voluntary: Firm initiated
Recall number
Z-1072-2022

Ongoing Class II Medical devices

Recall started
22 December 2021
Reason
Top cap may loosen and detach if the Universal Chuck becomes jammed and the user attempts to manually free the device, internal ball bearings may fall out onto the surgical field and cause surgical delay or, and if not recovered, adverse tissue reaction and infection.
Distribution
US Nationwide distribution.
Initiated
Voluntary: Firm initiated
Recall number
Z-0634-2022

Terminated Class II Medical devices

Recall started
19 November 2020
Terminated
1 July 2022
Reason
RIA 2 reamer head breakage exceeds the expected occurrence rate resulting in adverse tissue reaction, soft tissue damage, and/or bone damage, when the recommended surgical techniques are not followed
Distribution
Nationwide Foreign:countries: United Arab Emirates, Austria, Australia, Belgium, Switzerland, China, Czech Republic, Germany, Spain, United Kingdom, Ireland, Israel, Italy, Singapore,
Initiated
Voluntary: Firm initiated
Recall numbers
Z-0575-2021, Z-0574-2021, Z-0581-2021, Z-0577-2021, Z-0583-2021, Z-0584-2021, Z-0576-2021, Z-0580-2021, Z-0573-2021, Z-0572-2021, Z-0571-2021, Z-0578-2021 and 5 more

Terminated Class III Medical devices

Recall started
21 September 2020
Terminated
30 December 2022
Reason
Incorrectly Labeled 'general medical device,' printed on the statutory label of the SYNMESH CAGE SYSTEM instead of 'specially controlled medical device"
Distribution
International distribution the country of Japan Only.
Initiated
Voluntary: Firm initiated
Recall numbers
Z-0412-2021, Z-0414-2021, Z-0407-2021, Z-0415-2021, Z-0410-2021, Z-0417-2021, Z-0404-2021, Z-0405-2021, Z-0408-2021, Z-0406-2021, Z-0409-2021, Z-0411-2021 and 3 more

Terminated Class II Medical devices

Recall started
21 July 2020
Terminated
18 February 2022
Reason
May have one or more dimensional features out of tolerance includes: thread pitch diameter depth, thread minor diameter depth, plate thickness and end length out of tolerance that can potentially result in a reduced locking strength of an LCP screw
Distribution
US Nationwide distribution.
Initiated
Voluntary: Firm initiated
Recall number
Z-2816-2020

Terminated Class II Medical devices

Recall started
16 September 2019
Terminated
24 April 2020
Reason
The subject product measures 4.0mm in diameter instead of 3.5mm.
Distribution
Distributed to NJ.
Initiated
Voluntary: Firm initiated
Recall number
Z-0223-2020

Terminated Class II Medical devices

Recall started
5 September 2019
Terminated
23 June 2020
Reason
Modified outside of approved manufacturing process
Distribution
AR
Initiated
Voluntary: Firm initiated
Recall number
Z-0349-2020

Terminated Class II Medical devices

Recall started
12 September 2018
Terminated
10 April 2020
Reason
The product inside the package does not match the label. The product was labeled as long thread screws that have a 6mm thread length but were actually short thread screws with a 4mm thread length.
Distribution
US Distribution to the following states: AR, AZ, FL, IL, NM, OH, and TX.
Initiated
Voluntary: Firm initiated
Recall number
Z-0238-2019

Terminated Class II Medical devices

Recall started
4 May 2018
Terminated
21 October 2019
Reason
The adapter may demonstrate a degradation of function as the final products were assembled with ball bearings of high carbon content that is likely to rust prematurely.
Distribution
USA (nationwide) Distribution to the states of : AK, CA, FL, ID, IN, KS, KY, LA, MD, MI, MT, NC, NJ, NY, OH, OK, PA, SD, TN, TX, UT, WI, and WV.
Initiated
Voluntary: Firm initiated
Recall number
Z-1916-2018

Terminated Class II Medical devices

Recall started
2 April 2018
Terminated
16 October 2019
Reason
There is a potential for microspores to form on the hollow handle of the Sciatic Nerve Retractor. The pores may increase in size, allowing fluid to enter the hollow handle.
Distribution
US Nationwide and Canada
Initiated
Voluntary: Firm initiated
Recall numbers
Z-1758-2018, Z-1759-2018

Terminated Class II Medical devices

Recall started
5 March 2018
Terminated
28 February 2020
Reason
Affected screw gauges incorrectly measure screws 5.41mm shorter than the actual overall screw length.
Distribution
Distributed to accounts in CA, IL, IN, KS, LA, MD, NC, NE, NJ, OR, TX, and VA. Foreign distribution to Canada.
Initiated
Voluntary: Firm initiated
Recall numbers
Z-2246-2018, Z-2247-2018, Z-2245-2018

Terminated Class II Medical devices

Recall started
26 July 2017
Terminated
10 September 2018
Reason
Possible lack of product sterility due to potential gaps/channeling in the seal of the package.
Distribution
Worldwide Distribution: US (Nationwide) to states of: AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, the District of Columbia, including Puerto R
Initiated
Voluntary: Firm initiated
Recall numbers
Z-0901-2018, Z-0907-2018, Z-0903-2018, Z-0906-2018, Z-0904-2018, Z-0905-2018, Z-0902-2018

Terminated Class II Medical devices

Recall started
21 July 2017
Terminated
10 July 2018
Reason
The locking mechanism and protective cap were missing from the sterile packed nails of the affected lot.
Distribution
TX, GA, PA, UT and Canada
Initiated
Voluntary: Firm initiated
Recall number
Z-0604-2018

A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.