Z-0167-2016Class II

2.7 mm Locking Screw SLF-TPNG with T8 Stardrive Recess 12mm. The Synthes modular Mini Fragment LCP System is...

Name: Z-0167-2016 2.7 mm Locking Screw SLF-TPNG with T8 Stardrive Recess 12mm. The Synthes modular Mini Fragment LCP System is...
Creator: Synthes (USA) Products LLC
Published: 2015-10-06
License: https://open.fda.gov/license/

Synthes (USA) Products LLC / initiated 2015-10-06 / Terminated / root cause: packaging

FDA source

Synthes (USA) Products LLC began a recall of 2.7 mm Locking Screw SLF-TPNG with T8 Stardrive Recess 12mm. The Synthes modular Mini Fragment LCP System is intended for fixation of fractures, osteotomies... on 2015-10-06. FDA classified it as Class II and gives the reason as "Specific lots of the SS 2.7mm locking screw have been mislabeled as SS 2.4mm locking screw". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0167-2016
Classification: Class II
Status: Terminated
Initiated: 2015-10-06
Posted: 2015-10-30
Terminated: 2016-07-15
Recalling firm: Synthes (USA) Products LLC
Product: 2.7 mm Locking Screw SLF-TPNG with T8 Stardrive Recess 12mm. The Synthes modular Mini Fragment LCP System is intended for fixation of fractures, osteotomies, nonunions, replantations, and fusions of small bones and small bone fragments.
Product code: HRS Plate, Fixation, Bone
Reason for recall: Specific lots of the SS 2.7mm locking screw have been mislabeled as SS 2.4mm locking screw.
Root cause tag: packaging
FDA root cause: Packaging
Action: Synthes sent an URGENT NOTICE: MEDICAL DEVICE NOTIFICATION UPDATED INFORMATION: CORRECTED LOT NUMBER SS 2.7mm Locking Screw, self-tapping letter dated January 13, 2014, to the affected customer. Please take the following actions: If you DO have any of the identified devices, please take the following steps: Call Synthes at 1-800-479-6329 to obtain a Return Authorization Number. Complete the Verification Section at the end of this letter by checking the appropriate box indicating affected product has been located. Also, please indicate the number of devices found and note the Return Authorization Number. Please include your name, title, telephone number and signature in the spaces provided. Return the Verification Form (page 3 of this letter) with the product to: Credit/Returns, Synthes. If you DO NOT have the identified product, please take the following steps: Complete the attached Verification Section at the end of this letter by checking the appropriate box indication that no affected product has been located. Please include your name, title, telephone number and signature in the spaces provided this return documentation acknowledges your receipt of medical device removal information. Return the documents to Synthes by: Fax: 1-866-792-5446 or Scan/email: [email protected] If you have any questions, please call 610-719-5450 or contact your Synthes Sales Consultant. For further questions please call 610-719-6500.
Quantity in commerce: 98
Distribution: US Distribution to the state of : TN
Product codes and lots: Part Number 202.212 Lot Number 3420620

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0167-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0167-2016	Class II	Terminated	Voluntary: Firm initiated	2015-11-04	2015-10-27

Product code HRS

K063049Class IISynthes (USA) Modular Mini Fragment Lcp SystemSynthes (Usa) / cleared 2006-12-18

Process control is the most common named cause of a device recall11 SEP 2026 / by Medical Device Manufacturing

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)