FDA Medical Device Recalls (openFDA)
DePuy Orthopaedics, Inc.: DePuy LifeLiner Stick & Cut Resistant Gloves Rt, Lg Part No. 5200-68-000 The gloves are designed to resist sticks and cuts and are not cut or puncture proof. These gloves are not required by any surgical technique.
- Recall number
- Z-1331-2013
- Recalling firm
- DePuy Orthopaedics, Inc.
- Product
- DePuy LifeLiner Stick & Cut Resistant Gloves Rt, Lg Part No. 5200-68-000 The gloves are designed to resist sticks and cuts and are not cut or puncture proof. These gloves are not required by any surgical technique.
- Status
- Terminated
- Initiated
- 2013-05-08
- Posted
- 2013-05-16
- Terminated
- 2014-01-14
- Reason
- LifeLiner Stick and Cut Resistant Gloves are being recalled because cases and individual glove packages were mispackaged, with right handed, large sized glove packaging containing left handed, large sized gloves.
- Root cause
- Labeling mix-ups
- Action
- DePuy Synthes Joint Reconstruction, a division of DePuy Orthopaedics, Inc.,sent a " Urgent Information Medical Device Recall Notice" dated May 8, 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Please cease further distribution or use of the affected gloves immediately. Our records indicate your hospital purchased the affected lot. The purpose of this communication is to inform you of this recall and request acknowledgement of receipt of this letter by signing and returning the Hospital/User Facility Reconciliation Form within 10 business days of receiving this notice. Response cards should be faxed to (574) 371-4964. Please contact your DePuy Synthes Joint Reconstruction Sales Representative for assistance returning any unused affected gloves. For product related questions, please contact your local DePuy Synthes Joint Reconstruction Sales Consultant. For clinical questions from surgeons, please contact DePuy Synthes Joint Reconstructions Scientific Information Office at 1-888-554-2482 (M-F; 8 a.m.- 5 p.m. EDT). For questions about device recall information provided, please call (574)371-4917 (M-F; 8 a.m. - 5 p.m. EDT).
- Quantity
- 180 gloves (120 gloves distributed in the US)
- Distribution
- Worldwide Distribution - US (nationwide) including the states of IL, OH, NC, SC, MN, NV, TN and WA., and the countries of UK, Netherlands and Canada.
- Lot, serial or model codes
- Lot - D12178C
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- FYE
- Firm FEI
- 1818910
- Firm city
- Warsaw
- Firm state
- IN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28